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Shukla Acetabular Cup - S9CUP

FDA UDI

Class I (US FDA UDI)

by Shukla Medical

Identity

Trade Name
Shukla Acetabular Cup - S9CUP FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Device Name
Blades, Ace Cup, 54mm, Starter & Finisher, Single Use, Sterile Packed FDA UDI
Model / Reference
SBLDACE-54-SP FDA UDI
Description
Blades, Ace Cup, 54mm, Starter & Finisher, Single Use, Sterile Packed FDA UDI

Identifiers

Primary DI / UDI-DI
SBLDACE54SP0 FDA UDI
FDA Product Code
HWB FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Acetabular Cup - S9CUP by Shukla Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shukla Medical

Sources (1)

  • FDA UDI bed7d56c-b746-404f-adda-f1730bf750ed 35 fields · synced May 30, 2026